Class II · Moderate risk
Sterile Water for Irrigation
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Livalo (pitavatstatin) (Pitavastatin Calcium)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of foreign tablets/capsules
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case
Affected NDC
66869-0404-90
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Livalo pitavastatin calcium NDC 66869-0404 |
4.18 mg/1 | Tablet, Film Coated Oral |
Kowa Pharmaceuticals America, Inc. | Rx |
- Recalling firm
- Kowa Pharmaceuticals America
- NDC code
- 66869-404-90
- Origin
- AL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0258-2025 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other particulate / foreign matter recalls from 2025
All particulate / foreign matter recalls
Class II · Moderate risk
Wegovy (semaglutide)
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II · Moderate risk
Wegovy (semaglutide)
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II · Moderate risk
Tri-Moxi+¿
Presence of particulate matter - Glass like particles.
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